K951329 is an FDA 510(k) clearance for the IMMUCHEM GAL-MW EA. This device is classified as a Enzymatic Methods, Galactose (Class I - General Controls, product code JIA).
Submitted by Icn Pharmaceuticals, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on November 9, 1995, 231 days after receiving the submission on March 23, 1995.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1310.
| 510(k) Number | K951329 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 1995 |
| Decision Date | November 09, 1995 |
| Days to Decision | 231 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Statement |
| Product Code | JIA — Enzymatic Methods, Galactose |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1310 |